- 无工作经验
- 本科
- 招1人
- 11-09 发布
职位描述
职位描述: 1.Actsas the China/Regional Lead for the designated global/regional studies andassists the Senior Manager/Manager, Clinical Operations in the dailyoperational matters related to the execution, management and monitoring of thetrials, such as review of informed consent forms, participating in site PSSVs,co-monitoring visits, close-out visits, drafting of these visit reports, reviewof IMP packages, etc. so as to ensure that the defined timelines and milestonesare being met in a timely and efficient manner. 2.Assiststhe global/regional project teams to provide technical and content expertisewithin China/Asia Pacific region during the course of the study, as well as identifyingpotential challenges and working with team to strategize possible solutions.3.Assists the Senior Manager/Managerof Clinical Operations in CDD to enhance process, functional and operationalefficiencies in the clinical development of their designated global/regionaltrials through sharing of information, best case examples etc. within CDD andacross the different PCUs4.Provides general CRO/vendoroversight in the management and progress of their designated global/regionaltrials in China/Asia Pacific region5.Participates in projectsand initiatives relating to better understanding of patient reality and hhcwithin area of work6.Assist in the improvementof EPCS committees and processes, wherever possible.Qualificationsand Expertise· Working knowledge of entire drug developmentprocess, including clinical plan development and execution of entire clinicalstudy chain, specifically within the China/Asia Pacific region· Detailed knowledge of Code of Federalregulations (CFRs), ICH guidelines, clinical operations, project management,and corporate /regional SOPs· Demonstrated ability to manage and coachreports who are CRO project managers and individual contributors· Good organizational, time management andattention to detail skills · Extremely proficient computer skillsincluding MS Word, Excel, and PowerPointStrong verbal,written and interpersonal communication skills, especially needed to workeffectively in a cross-functional and cross-cultural team environment, managingthat team as required 职能类别: 临床研究员
联系方式
SK大厦
公司信息
卫材药业(Eisai China Inc.) 卫材(Eisai)系世界知名医药跨国企业,本着“为人类健康保健服务-Human Health Care”的宗旨,于1996年在苏州工业园区投资成立了独资制药企业——卫材(中国)药业有限公司,其注册资本为3854万美元,总部设在上海,并已在全国设立了11个办事处和1个生产基地。目前,卫材在中国的产品主要涉及神经系统、消化系统、心血管系统等领域。 为配合中国地区业务发展之需, 现诚邀有志于与卫材共同发展的您加入我们的大家庭! 符合所述条件并有意者请于见本信息后10日内将个人简历、学历资格证明、身份证复印件、近期一寸彩照、有效联系方式寄往本公司,信封上务必注明应聘职位及工作地点。欢迎浏览公司网页。 我们提供的不仅仅是一份职业,而是您事业发展的机会! 特别提醒:在候选人未正式入职前,卫材(中国)药业有限公司不会安排其参加任何培训,更不会向其收取任何费用,请应聘者谨防受骗。
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